A Study of RhinAer Stylus for Treating Chronic Rhinitis

Launched by AERIN MEDICAL · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called the RhinAer Stylus for people suffering from chronic rhinitis, which is a condition that causes persistent nasal symptoms like congestion and runny nose. The goal is to see how effective this treatment is and how it affects certain markers in the body related to inflammation. The study is currently looking for participants who are between the ages of 22 and 85 and have been dealing with chronic rhinitis for at least a year. To qualify, individuals must be willing to undergo the RhinAer procedure and have a specific level of symptom severity.

Participants can expect to visit an Ear, Nose, and Throat (ENT) office where they will be evaluated for their condition and undergo the treatment if they meet the eligibility criteria. It's important that potential participants do not have certain nasal obstructions or recent complications like nosebleeds, and they should not be pregnant or breastfeeding. If you or someone you know has been struggling with chronic rhinitis and is interested in exploring this treatment option, participating in this study could provide valuable insights into its effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 22 to 85 years (inclusively).
• • 2. Willing and able to provide informed consent.
• • 3. Willing and able to comply with the patient-specific requirements outlined in the study protocol.
• • 4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
• • 5. Willing to undergo the RhinAer procedure
• • 6. Has a baseline rTNSS symptom score of ≥6 at time of screening
• • 7. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
• 8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria:
• • a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months.
• • OR
• • -b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months.
• Exclusion Criteria:
• • 1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area.
• • 2. Has seasonal rhinitis symptoms.
• • 3. Current or recent use of biologic therapy within past 3 months.
• • 4. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months.
• • 5. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure.
• • 6. Known or suspected to be pregnant or is lactating.
• • 7. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]).
• • 8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.'
• • 9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).
• • 10. Has had a nasal or sinus surgical procedure in the past six (6) months.
• • 11. Currently participating in another clinical research study or has participated in an interventional study within the past 3 months.
• • 12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period
• • 13. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.